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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER OCUSCAN RXP; ULTRASONIC PULSED ECHO IMAGING SYSTEM

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ALCON - IRVINE TECHNOLOGY CENTER OCUSCAN RXP; ULTRASONIC PULSED ECHO IMAGING SYSTEM Back to Search Results
Model Number 8065741076
Device Problem Incorrect Measurement (1383)
Patient Problem Postoperative refraction, unexpected (2642)
Event Type  Injury  
Event Description
A healthcare professional reported that some pts remained somewhat myopic in the surgery after the measurements were taken with the biometer.This report is for the pt that remained 1 diopter myopic.Add'l info was received from the facility who reported that the event was due to the human error when the biometric probe was used.The facility informed that the reported issue has always been pts' myopization: the biometer measured an axial length slightly smaller than real for all the pts; the pts have never remained hypermetropic.According to the facility's opinion the ophthalmologist applied more pressure than the advisable one with the biometer probe to the pts' eyes when taken the measurements.The facility also informed that they were going to take more care and pay more attention at revision time from now on.No add'l info is expected.This is the fourth of third medical device reports being filled for this event.
 
Manufacturer Narrative
A service visit has been performed.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when add'l reportable info becomes available.No add'l info is expected.(b)(4).
 
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Brand Name
OCUSCAN RXP
Type of Device
ULTRASONIC PULSED ECHO IMAGING SYSTEM
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
janet moran
6201 south freeway
r3-48
fort worth, TX 76134
8146152742
MDR Report Key3891733
MDR Text Key15126888
Report Number2028159-2014-01080
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K842757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Type of Report Initial
Report Date 05/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8065741076
Device Catalogue Number8065741076
Other Device ID Number1.15
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/14/2014
Initial Date FDA Received06/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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